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Dynarex Three-Way Stopcock

FDA 510(k)

Class II (US FDA 510(k))

510(k) K172266

by Dynarex Corp.

Identifiers

510(k) Number
K172266 FDA 510(k)
FDA Product Code
FMG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5440 FDA 510(k)
Regulation Number
880.5440 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Dynarex Three-Way Stopcock is a stopcock, I.V. set (FDA Product Code: FMG) designed to regulate and direct the flow of intravenous fluids and medications. It functions as a multi-port valve to control fluid pathways, enabling gravity feed, sampling, bolus injection, and the elimination or reflux of solutions during administration. This device is intended for use in vascular access systems to manage fluid delivery in clinical settings.

This device is supplied as a single-use medical instrument and is classified as a Class II general hospital device under FDA regulations. It is cleared through the Traditional 510(k) pathway and must be handled in accordance with sterile medical device protocols. The stopcock is intended for use in intravenous therapy and is not MRI-compatible. Storage should follow manufacturer guidelines to maintain sterility and functionality, ensuring compliance with regulatory standards.

Frequently asked questions

What clinical scenarios is the Dynarex Three-Way Stopcock designed to support during intravenous therapy?

The Dynarex Three-Way Stopcock is specifically designed to regulate and direct the flow of intravenous fluids and medications in vascular access systems. It allows clinicians to control pathways for gravity feed, sample collection, bolus injections, and the elimination or reflux of solutions—critical functions during fluid administration, medication delivery, or monitoring of patient responses.

Is the Dynarex Three-Way Stopcock reusable, or is it intended for single-use only?

The Dynarex Three-Way Stopcock is explicitly labeled as a single-use medical instrument. Like all sterile devices, it must be discarded after one use to maintain patient safety and comply with sterile medical device protocols.

How should I store the Dynarex Three-Way Stopcock to ensure sterility and functionality?

The device must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. Since it is a sterile, single-use item, it should remain in its original packaging until use, protected from contamination, moisture, and extreme temperatures. Always follow the packaging instructions to maintain compliance with regulatory standards.

What regulatory pathway was used for FDA clearance of the Dynarex Three-Way Stopcock?

The Dynarex Three-Way Stopcock was cleared through the Traditional 510(k) pathway, which demonstrates that it is substantially equivalent to a legally marketed predicate device. This clearance was granted under FDA Product Code FMG and classified as a Class II general hospital device.

Are there different sizes or models of the Dynarex Three-Way Stopcock, or is it available in a single configuration?

The provided data lists multiple FEI numbers (e.g., 3009211636, 3032916632), which typically indicate different lot or batch identifiers rather than distinct sizes or models. However, the device itself is described as a standard three-way stopcock for IV sets, implying a single functional design. For exact sizing or model variations, refer to the manufacturer’s catalog or technical specifications.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K172266 FDA 510 (k) - Dynarex Three-Way Stopcock, Dynarex Three-Way Stopcock (K172266) — FDA 510(k) | Innolitics, Home Dynarex Corporation

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Dynarex Corp.
FDA Applicant
Dynarex Corporation

Sources (1)

  • FDA 510(k) K172266 24 fields · synced Sep 20, 2026